Brand Name | ANTI-D (SERIES 4) MONOCLONAL BLEND |
Type of Device | BLOOD GROUPING REAGENT |
Manufacturer (Section D) |
IMMUCOR, INC. |
3130 gateway drive |
norcross GA 30091 5625 |
|
Manufacturer (Section G) |
IMMUCOR, INC. |
3130 gateway drive |
|
norcross GA 30091 5625 |
|
Manufacturer Contact |
howard
yorek
|
3130 gateway drive |
norcross, GA 30091-5625
|
7704412051
|
|
MDR Report Key | 8130200 |
MDR Text Key | 129601763 |
Report Number | 1034569-2018-00268 |
Device Sequence Number | 1 |
Product Code |
KSZ
|
UDI-Device Identifier | 10888234000556 |
UDI-Public | 10888234000556 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | 103523/0.0 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
health professional,user faci |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
12/04/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/04/2018 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Expiration Date | 12/31/2019 |
Device Catalogue Number | 0006412 |
Device Lot Number | 504806 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 11/14/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 04/18/2018 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |